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Advisory Committee for Pharmaceutical Science

Office of Pharmaceutical Science

Initially chartered as the Generic Drugs Advisory Committee (1990-1995)

Mission:

  • give advice on scientific and technical issues concerning the safety and   effectiveness of human generic drugs
  • give advice on any other product for which the FDA has regulatory responsibility
  • make appropriate recommendations to the FDA Commissioner
  • review Agency sponsored intramural and extramural biomedical research programs

Current Members

Stephen Byrn, Ph.D. (Chair) Purdue Univ.
Kathleen Lamborn, Ph.D. Univ. of Cal., S.F.
Gloria Anderson, Ph.D. Morris Brown College
Mary Berg, Pharm.D. Univ. of Iowa
Judy Boehlert, Ph.D. Boehlert Associates, Inc.
John Doull, M.D., Ph.D. Univ. of Kansas
William Jusko, Ph.D. SUNY at Buffalo
Vincent Lee, Ph.D. Univ. of Southern California
Joseph Bloom, Ph.D. Univ. of Puerto Rico
Jurgen Venitz, Ph.D  Va. Commonwealth Univ.
Nair Rodriquez-Hornedo, Ph.D. Univ. of Michigan

ACPS Subcommittees:

ACPS subcommittees include two members from ACPS and make preliminary recommendations regarding specific issues for subsequent action by the full committee.

  • Nonclinical Studies Subcommittee (NCSS)
  • Orally Inhaled and Nasal Drug Products Subcommittee (OINDP)

Nonclinical Studies Subcommittee (NCSS)

Objectives:

  • Provide advice on scientific approaches and mechanisms to improve:
    • Nonclinical information for effective drug development
    • Predictivity of nonclinical tests for human outcome
    • Linkage between nonclinical and clinical studies

  • Facilitate collaboration among FDA, industry, academia, and the public.

NCSS Members

    John Doull, M.D., Ph.D. (Chair)  University of Kansas
    Jay Goodman, Ph.D.                   Michigan State Univ.
    Gloria Anderson, Ph.D                Morris Brown College (Consumer Representative)
     Joy Cavagnaro, Ph.D

    FDA Representatives
    David Essayan, M.D., CBER
    James MacGregor, Ph.D., NCTR
    Daniel Casciano, Ph.D., NCTR

Orally Inhaled and Nasal Drug Products Subcommittee (OINDP)

Objectives:

  • Provide advice on the following three draft Guidances for Industry:
    • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products  Chemistry, Manufacturing, and Controls Documentation
    • Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products,  Chemistry, Manufacturing, and Controls Documentation
    • Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

  • Address questions related to the content uniformity of orally inhaled and nasal drug products.

  • Address questions related to in vitro and in vivo bioavailability and bioequivalence testing for orally inhaled and nasal drug products.

OINDP Members

    Vincent H. L. Lee, Ph.D. (Chair)   Univ. of Southern Cal.
    James Li, M.D., Ph.D.                   Mayo Clinic
    Stanley J. Szefler, M.D.                 National Jewish Center
    Richard Ahrens, M.D.                   University of Iowa
    Gloria Anderson, Ph.D.                 Morris Brown College (Consumer Representative)

    FDA Representatives
    Wallace P. Adams, Ph.D.
    Guirag Poochikian, Ph.D.

ACPS transcripts and related information

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FDA/Center for Drug Evaluation and Research
Last Updated: August 09, 2001
Originator: OTCOM/DLIS
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